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Next Step for FDA's Deeming Regulations

Public comment period drew more than 75,000 submissions.

August 11, 2014, 04:55 pm

WASHINGTON, D.C. -- With the closing of the public comment period, the Food and Drug Administration (FDA) is moving on to the next phase of its bid to regulate additional tobacco products -- including electronic cigarettes and cigars.

The agency published its proposed deeming rule in April and drew 75,735 comments during the public comment period, which ended Aug. 8, according to New York-based financial services firm Cowen & Co. The 60-day comment period was originally set to end July 9, but was extended an additional 30 days.

Cowen & Co. said while premium cigars appear to be the center of attention, comments varied and addressed different topics within the proposed regulation.

In a report issued Monday morning, the firm noted that more than 47,000 submissions related to premium cigars, "while approximately 13,500 specifically represented what we believe to be form letters, noting 'As an adult consumer of premium cigars' within the comment."

In addition, the FDA received approximately 3,500 submissions mentioning electronic cigarettes in some variation, including 1,653 comments specifically related to vaping, 545 that called out e-liquids, and 380 that spoke to advertising.

Next up, the FDA is tasked with sorting through the thousands of submissions, which is expected to take several months.

While the agency's 2011 menthol report received more submissions (approximately 175,000), the proposed deeming rule "covers a broader spectrum of products than menthol, including cigars, e-cigarettes and vaping. Given the increased complexity around these multiple product types, we think this could result in a longer review process," said Vivien Azer, Cowen & Co.'s director and senior research analyst specializing in the beverage and tobacco sectors.

"As Mitch Zeller, director of the Center for Tobacco Products at the FDA, has mentioned on multiple occasions, the FDA's mission is to take a science-based approach. While it should be easy enough to sort through the many form letters submitted, they will have to take a much closer look at the science, which we believe could take many months," Azer added.

In its comments to the FDA, Lorillard Inc., parent of blu eCigs, acknowledged that additional science evaluation is needed in the area of e-cigarettes, though "the science developed to date shows that electronic cigarettes have the potential to play a critical role in smoking risk reduction and to significantly advance the public health. Available scientific information indicates that electronic cigarettes do not encourage smoking initiation; that they could help some smokers quit smoking; and that electronic cigarettes expose users to far lower levels of harmful or potentially harmful constituents (HPHCs) than conventional cigarettes. All of these data suggest that electronic cigarettes can offer long-term, population-level health benefits.

"Given this potential, Lorillard urges FDA to implement its tobacco product authorities for electronic cigarettes in a thoughtful and prudent manner, proportional to the harm reduction potential that these products present. Aspects of the existing regulatory system for conventional tobacco products are not well-suited for electronic cigarettes," Lorillard concluded.

The Greensboro, N.C.-based tobacco company said it supports regulation of e-cigarettes, including several parts of the FDA proposal such as registration of electronic cigarette manufacturers; listing of electronic cigarette products; submission of electronic cigarette ingredients; restrictions on youth access; reasonable warnings for electronic cigarettes, including nicotine warnings; and limitations on vending machine sales.

"Lorillard stands ready to work collaboratively with FDA to advance the science surrounding electronic cigarettes and to implement a thoughtful regulatory system for this product category," the company stated.

NACS, the Association for Convenience & Fuel Retailing, also weighed in, expressing support for the proposed age verification provision requiring retailers to ensure that anyone who seeks to purchase e-cigarettes is at least 18 years of age. NACS has encouraged its members to adopt this approach as a best practice since before the FDA’s proposal was released.

However, the Alexandria, Va.-based association did express some concerns with the proposed rule. For example, NACS opposes a provision that would require sellers of individual cigars to place a warning statement adjacent to each cash register in a store. NACS also asked for the rule’s effective date to be extended from 30 days after it is finalized to 120 days. This would provide retailers sufficient time to train their employees to comply with the new regulations, NACS said in its comments.

In addition, NACS argued that the final rule should be extended to cover online sales of e-cigarettes and other tobacco products, and not only brick-and-mortar sales. NACS further urged the FDA to enforce its regulations against tribal retailers to the same extent that it enforces them against non-tribal sellers.

Among other comments sent to the FDA was a letter signed by 29 state attorneys general. The letter urges the FDA to strengthen its proposed regulation of e-cigarettes, with the goal of protecting young people from the harms of nicotine addiction. Among other recommendations, the attorneys general asked the FDA to prohibit flavors in e-cigarettes, and to restrict advertising and marketing for e-cigarettes in the same manner as for cigarettes, according to New York State Attorney General Eric Schneiderman.

"Today, we urge the FDA to do the right thing and protect our youth from yet another tobacco epidemic," the letter stated. "We don't need these e-cigarettes aimed at our youth. What we need are strong FDA regulations that protect the public health and protect our youth from a lifetime of nicotine addiction. The FDA should ban all flavored electronic cigarettes and should prohibit e-cigarette advertising on television, radio and youth-oriented magazines."